Université Paris Descartes, Faculté de médecine, AP-HP, groupe hospitalier Cochin Broca Hôtel Dieu, site Hôtel Dieu, Paris, France.
Gynecol Oncol. 2013 Jun;129(3):459-62. doi: 10.1016/j.ygyno.2013.02.035. Epub 2013 Mar 6.
The objective of this study is to report the efficacy and tolerance of single agent bevacizumab (BEVA) in relapsing ovarian cancer patients treated in a single institution outside a clinical trial.
To receive single agent BEVA, patients must have to relapse after at least one previous line of chemotherapy and to not have clinical conditions associated with high risk of gastrointestinal perforation. Dose-intensity of BEVA was 2.5mg/kg/week.
37 previously treated patients (33 with platinum resistant disease) were included in this retrospective analysis. The median number of BEVA infusion by patient was 5 (range: 1-61). The most frequent adverse effect was arterial hypertension, observed in 23 patients (62%), including 11 with G3 (30%) and 1 with G4. No intestinal perforation was reported. Tumor response rate according to CA 125 level (GCIG criteria) was 37% (11 of 30 patients). The median PFS and OS were 4 (range: 1 to +56) and 16 (range: 1 to +65) months (ms), respectively. 12-ms PFS was 25% (95% CI: 11-39%). The PFS tended to be better in patients who experienced grade 3-4 arterial hypertension during the first month of treatment (median: 10ms) compared to patients who did not (median: 3ms) (HR: 0.49 (95% CI: 0.18-1.03), p=0.06 by log rank test).
Single agent BEVA could be a reasonable option with favorable therapeutic index in pretreated ovarian cancer patients who do not want to suffer the side effects of chemotherapy provided to exclude those with high risk of intestinal perforation and carefully monitor blood pressure.
本研究旨在报告单药贝伐珠单抗(BEVA)在一家临床试验之外的单机构中治疗复发性卵巢癌患者的疗效和耐受性。
接受单药 BEVA 治疗的患者必须在至少一线化疗后复发,且无胃肠道穿孔高风险相关的临床状况。BEVA 的剂量强度为 2.5mg/kg/周。
37 名先前接受过治疗的患者(33 名患者对铂类耐药)纳入本回顾性分析。每位患者接受 BEVA 输注的中位数为 5 次(范围:1-61 次)。最常见的不良反应是动脉高血压,观察到 23 例患者(62%),其中 11 例为 3 级(30%),1 例为 4 级。未报告肠道穿孔。根据 CA 125 水平(GCIG 标准),肿瘤缓解率为 37%(30 例患者中的 11 例)。中位无进展生存期(PFS)和总生存期(OS)分别为 4 个月(范围:1 至+56 个月)和 16 个月(范围:1 至+65 个月)。12 个月 PFS 为 25%(95%CI:11-39%)。在治疗的第一个月发生 3-4 级动脉高血压的患者中,PFS 中位数为 10 个月,与未发生高血压的患者相比(中位数:3 个月),PFS 有改善趋势(风险比:0.49(95%CI:0.18-1.03),对数秩检验 p=0.06)。
对于不愿接受化疗副作用但排除肠道穿孔高风险且需仔细监测血压的复发性卵巢癌患者,单药 BEVA 可能是一种具有良好治疗指数的合理选择。